MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 33MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.
Event or Problem Description
A patient reports progressive pain and no event of fall or knock.On (b)(6) 2020 surgeon decide to remove broken exeter v40 stem and change it for a new one and a femoral head with simplex bone cement with tobramycin.The surgery finished successfully, the patient had been received 2 surgeries before of this; 2nd surgery have been performed on (b)(6) 2012 and the surgeon removed exeter total hip prosthesis plus trident cup.Then it was implanted zimmer (not stryker) cup, insert and screws with exeter stem and v40 head.
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a exeter stem was reported.The event was confirmed via medical review.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: no clinical or pmh, no patient demographics, no operative reports, no exam of explanted components.X-ray confirms fracture of exeter stem, but no other information available to create a medical report.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: no clinical or pmh, no patient demographics, no operative reports, no exam of explanted components.X-ray confirms fracture of exeter stem, but no other information available to create a medical report.No further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
A patient reports progressive pain and no event of fall or knock.On (b)(6) 2020 surgeon decide to remove broken exeter v40 stem and change it for a new one and a femoral head with simplex bone cement with tobramycin.The surgery finished successfully, the patient had been received 2 surgeries before of this; 2nd surgery have been perfomed on sept, 2012 and the surgeon removed exeter total hip prosthesis plus trident cup.Then it was implanted zimmer (not stryker) cup, insert and screws with exeter stem and v40 head.Update: "1.Please estimate any surgical delay, even if under a minute: none".

• Brand Name: EXETER V40 STEM 33MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9888009
• Report Number: 0002249697-2020-00611
• Device Sequence Number: 14180460
• Product Code: JDI
• UDI-Device Identifier: 04546540153227
• UDI-Public: 04546540153227
• Combination Product (Y/N): N
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2013
• Device Model Number: 0580-1-330
• Device Catalogue Number: 0580-1-330
• Device Lot Number: G2946177
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention